FDA 305A.
Trial name or title | Randomized, controlled trial of SCH 56592 oral suspension versus fluconazole suspension in the treatment of oropharyngeal candidiasis (OPC) in HIV positive patients |
Methods | Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and re monitored for safety and efficacy of study treatment. |
Participants | Estimated enrolment: 300 Inclusion criteria: 18 yrs or older; HIV positive; Have thrush (OC); agree to sexual abstinence of use effective barrier methods of birth control; Able to take study medication and return to clinic |
Interventions | |
Outcomes | |
Starting date | August 1998 |
Contact information | |
Notes | Study completed. No publications provided. Clincal Trials.gov: NCT00002446 |